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Completed

NCT Number: NCT03106441

Preoxygenation Optimisation in Obese Patients

Oro-tracheal intubation in operating room in obese patients with BMI > 35kg/m2 remains a critical event. The aim of this study is to determine whether Nasal High Flow Therapy by nasal cannula Optiflow® is more efficient than the BIPAP preoxygenation before orotracheal intubation after crash induction in obese patients

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Key information

Conditions

Severe Obesity Design as BMI > 35kg/m2

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nantes University Hospital, Hôtel Dieu, Medical intensive care unit

Nantes, 44093, France

About this study

This study will be designed as followed : Patients will be randomized in 2 groups :

  • Preoxygenation during 4 minutes with High Flow Nasal Cannula (60l/min FiO2 (fraction of inspired oxygen) = 1) before orotracheal intubation after crash induction. The device will be maintained in place throughout the intubation procedure in order to achieve apnoeic oxygenation.
  • Or Preoxygenation during 4 minutes with Bi-level Positive Airway Pressure (BIPAP) with Expiratory Positive Airway Pressure (EPAP) + 5 cm H2O and Inspiratory Airway Positive Airway Pressure (IPAP) + 15, meaning a 10cm H2O pressure support. The facial mask with be removed after before crash induction enabling laryngoscopic vision.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Obese patient with BMI > 35kg/m2
  • Age between 18 and 80 years
  • Requiring a crash induction sequence for oro-tracheal intubation.

Exclusion criteria

  • Pulse oxymetry < 90% in ambient air
  • Haemodynamic instability
  • Burned patient
  • Indication of intubation vigil in spontaneous ventilation
  • Patients with a documented Cormack IV exposition before inclusion
  • Protected adult
  • Pregnancy
  • Lack of consent
  • Patient already enrolled in an other randomized study looking forward improving preoxygenation quality.
  • Lack of French social protection

Treatment and study plan

High flow oxygen therapy by nasal cannula. Optiflow®

Device

Patients randomized in interventional group will received a four minutes preoxygenation period with High Flow nasal cannula (60 l/mn FiO2 = 1) before orotracheal intubation. The device will be maintained in place throughout the intubation procedure in order to achieve apnoeic oxygenation.

Facial mask oxygenation in BIPAP ventilation

Device

Patients randomized in BIPAP group will receive a four minutes preoxygenation with EPAP 5, IPAP 15 FiO2 = 1 for a pressure support of 10 cm H2O. The facial mask with be removed after before crash induction enabling laryngoscopic vision

Primary outcomes

  1. Expired fraction of oxygen at the end of intubation

    Time frame: 2 minutes

    To determine whether High-Flow nasal cannula used during the preoxygenation in obese patient is more efficient than BIPAP preoxygenation.

Secondary outcomes

  1. Improvement of quality of preoxygenation

    Time frame: 4 minutes

    duration of proceedings

  2. Reduction in side effects incidence related to intubation

    Time frame: 1 hour

    Notification of adverse events during the intubation period

  3. morbi-mortality during surgery

    Time frame: 6 hour

    Per and postoperative complication rate

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

PREOPTI-POOP: Preoxygenation Optimisation in Obese Patients: High-flow Nasal Cannula Oxygen Versus Non-invasive Ventilation : A Single-centre Randomized Controlled Study. "

Acronym: PREOPTI-POOP

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 10, 2017
Registry last updated
Sep 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.